AbbVie’s elagolix for endometriosis painSeptember 14, 2018
The US FDA gave clearance to elagolix (Orilissa), an oral gonadotropin-releasing hormone (GnRH) antagonist for women with severe endometriosis pain.
This nonpeptide small molecule drug inhibits endogenous GnRH signaling by binding competitively to GnRH receptors in the pituitary gland. The administration of the drug results in dose-dependent suppression of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), leading to decreased blood concentrations of ovarian sex hormones, estradiol and progesterone
Approved under priority review, Orilissa is the first oral treatment for the management of moderate to severe pain associated with endometriosis in over
a decade and is expected
to be available in the U.S.
retail pharmacies in early August 2018.
Endometriosis-associated pain is often managed with medicines such as oral contraceptives, NSAIDs, opioids and hormonal therapies, which can work for some women, but very few are specifically indicated for the treatment of endometriosis. In more extensive cases, surgical interventions are often pursued, and may not be curative for all individuals.
The approval is supported by data from two replicate studies in the largest endometriosis Phase 3 study programme conducted to date, which evaluated nearly 1,700 women with moderate to severe endometriosis pain, announced AbbVie and Neurocrine Biosciences in a press release.
The recommended duration of use for Orilissa is up to 24 months for the 150 mg once-daily dose and up to six months for the 200 mg twice daily dose, as it causes a dose-dependent decrease in bone mineral density (BMD).